Oral candidiasis is an extremely virulent, painful, and life-threatening disease for the aged and debilitated and is especially prevalent in care centers for the aged with chronic debilitating ailments, cancer hospitals and transplantation centers. Most patients suffering from oral candidiasis find it practically impossible to tolerate solid foods and even solid medicines since the pain caused by contact of solids with infected areas is unbearable. Therefore, such patients can only ingest liquids. The medical problems of these patients are compounded by the fact that the patients are usually already in a debilitated state brought on by an underlying disease such as cancer, diabetes, emphesema or serious bacterial, viral or other fungal infections even before contracting oral candidiasis. The inability of the patient to ingest solids most often results in a further weakening and debilitation which, added to the effects of the underlying illness, usually results in the death of the patient.
The treatment generally indicated for combatting oral candidiasis is the use of antifungal agents such as nystatin in topical form, such as oral suspension or tablets. In order to be optimally effective, the nystatin must be supplied to the infected areas and maintained at a constant effective saliva level over a sustained period of time. Unfortunately, in the case of many patients, especially those with buccal ulcers, the nystatin suspension will not remain in contact with infected areas for sufficiently long periods to effectively combat the infection. The nystatin suspension is too easily washed away from infected areas. Thus, the effectiveness of such nystatin treatment is drastically curtailed since the suspension will not usually remain in contact with infected areas for sufficiently long periods to combat the infection.
Furthermore, as indicated, in most victims of this virulent disease, pain caused by any irritation in the oral cavity and esophagus becomes so unbearable that the slightest additional discomfort in the infected areas such as caused by the use of conventional nystatin tablets cannot be tolerated. Presently, nystatin tablets or lozenges which are normally used are hard and develop rough edges as they dissolve in the mouth and thereby further contribute to irritation. Suspensions may not cause irritation; however, they suffer from the dangerous disadvantage that they do not remain in contact with infected areas for sufficiently long periods to effectively combat the infection.
U.S. Pat. No. 3,312,594 to Cyr et al discloses long-lasting troches or pastilles which do not disintegrate or lose their integrity for 30 minutes or more, and contain a medicament used in treating the oral cavity for oral lesions, oral moniliasis, stomatitis and the like. The Cyr et al troches or pastilles include an anhydrous adhesive, which functions as carrier or vehicle as well, formed of 30 to 40% pectin, 30 to 40% gelatin and 30 to 40% carboxymethylcellulose (% being based on total weight of all three components). The anhydrous combination adhesive of large quantities of pectin, gelatin and carboxymethylcellulose, when wetted, causes the troche containing same to adhere to the oral mucous membranes and thus basically remain in a single localized infected area for prolonged periods while slowly and gradually releasing medication.
Unfortunately, although the Cyr et al formulation is excellent for treating certain types of oral conditions, it is not particularly well tolerated by the patient suffering from oral candidiasis. As indicated, the Cyr et al troche does not readily disintegrate or lose its integrity due to the presence of an anhydrous adhesive as discussed above. Thus, it will not have the smooth velvety confortable muscilagenous mouth feel which is necessary if it is to be tolerated by the suffering patient, but instead will be rough, sticky and irritatingly adhesive-like. Furthermore, the Cyr et al troche remains localized and does not provide for maximum distribution of medicine throughout the oral mucosa and thus would not be particularly effective against widespread oral infection.
An ideal medicament for treating a patient suffering from oral candidiasis is one in the form of a pastille which is at all times free of rough edges and which contains an effective antifungal agent, is smooth, velvety, comfortable and sufficiently muscilageous so that it can be tolerated in the oral cavity and will slowly dissolve without adhering to the oral muscous membrane to distribute antifungal agent throughout the oral mucosa so that the antifungal agent will be retained at the sites of infection for a sufficiently long time to permit efficacy. The present invention provides such an ideal medicament.